- Theralase Technologies (TSXV:TLT) signed a clinical development agreement with Ferring Pharmaceuticals to evaluate a new combination therapy for high-risk Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer
- Theralase is a clinical-stage pharmaceutical company developing light, radiation, sound and drug-activated small molecule compounds to destroy cancers, bacteria and viruses
- Theralase stock (TSXV:TLT) last traded at C$0.24 and has given back 15.52 per cent year-over-year
Theralase Technologies (TSXV:TLT) signed a clinical development agreement with Ferring Pharmaceuticals, a top name in reproductive health, urology and gastroenterology, to evaluate a new combination therapy for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
This content has been prepared as part of a partnership with Theralase Technologies Inc. and is intended for informational purposes only. The author owns shares in the company, but has not been paid by Theralase Technologies Inc. or any third party for this article.
BCG immunotherapy, the standard-of-care for NMIBC, produces no significant response in one third of patients, with 50 per cent of those with an initial response suffering a recurrence of the disease. According to the American Cancer Society, an estimated 84,870 new cases were reported in the US in 2025.
The new combination therapy, building upon Theralase’s ongoing clinical program, will pair the company’s light-activated small molecule Ruvidar with Ferring’s intravesical non-replicating gene therapy Adstiladrin, with a focus on patients with Carcinoma In-Situ (CIS) with or without papillary tumors (±Ta/T1). Patients will be enrolled and treated in the United States, subject to approval from the US Food and Drug Administration (FDA), with potential expansion into Canada or other countries.
Adstiladrin is the first and only intravesical gene therapy approved by the FDA for high-risk BCG-unresponsive NMIBC CIS, delivering the human interferon alpha-2b gene directly to bladder cells, facilitating a number of anticancer and immunomodulatory effects.
The investigational Ruvidar, for its part, breaks through cancer cell walls and delivers cytotoxic effects to destroy cancer cells and induce immunogenic cell death, prompting the immune system to defend the body and adapt to the medication’s prompts.
Theralase will sponsor the study and benefit from clinical overview through a joint development committee alongside Ferring.
Management commentary
“The introduction of Adstiladrin, as the first intravesical gene therapy, filled a critical unmet need for patients with BCG-unresponsive NMIBC who faced limited treatment options and needed an alternative to invasive bladder removal surgery,” Ashish Kamat, president of the International Bladder Cancer Group and endowed professor of urologic oncology surgery and cancer research at University of Texas MD Anderson Cancer Center in Houston, Texas, said in Monday’s news release. “As the BCG-unresponsive treatment paradigm continues to evolve, the combination of complementary therapies may offer additional treatment options to definitive therapy. This new study offers an opportunity to explore the possibility of enhancing efficacy and durability of response with a combination of a promising, investigational light-activated small molecule with the leading gene therapy in NMIBC.”
“Underscoring our ambition to establish Adstiladrin as the backbone therapy in NMIBC, this collaborative clinical study with Theralase aims to explore whether combination approaches can further enhance patient outcomes, building on the strong foundation Adstiladrin has established in treating this challenging disease,” added Daniel Shoskes, vice president and global medical director for uro-oncology at Ferring Pharmaceuticals.
“We are honored to collaborate with Ferring, a worldwide leader in uro-oncology with deep expertise in bladder cancer treatment,” concluded Roger DuMoulin-White, president, chairman and chief executive officer at Theralase. “As we approach completion of our clinical study and regulatory submissions for Ruvidar, this partnership provides the perfect opportunity to investigate whether we can deliver even greater benefits to patients through innovative combinational approaches.”
About Theralase Technologies
Theralase Technologies is a clinical-stage pharmaceutical company developing light, radiation, sound and drug-activated small molecule compounds to destroy cancers, bacteria and viruses.
Theralase stock (TSXV:TLT) last traded at C$0.24 and has given back 15.52 per cent year-over-year.
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